Early and Late Effects of Nefopam in Multimodal Analgesia After Total Hip Arthroplasty (NEFARTHRO)

Launched by UNIVERSITY HOSPITAL, TOURS · Apr 2, 2024

Keywords

ClinConnect Summary

The NEFARTHRO trial is a research study aimed at understanding how a medication called nefopam can help manage pain after total hip replacement surgery. The trial compares two ways of giving nefopam: as a quick injection (bolus) and as a continuous drip through an infusion pump, against a placebo (a treatment with no active medication). The main goal is to see how much morphine, a common pain medication, patients need in the first 24 hours after their surgery when nefopam is used as part of their pain management plan.

To be eligible to participate in this trial, you need to be at least 18 years old, fluent in French, and scheduled for a total hip replacement surgery. You should not have certain medical conditions like severe liver or heart issues, and you must be able to provide informed consent (which means you understand the trial and agree to participate). If you join the study, you will be followed for six months to see how well the pain management plan works for you. This trial is currently not yet recruiting participants, but it's an important step in finding better ways to handle pain after surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient aged ≥ 18 years, fluent in French.
• • Planned primary or secondary total hip replacement, regardless of surgical approach or type of prosthesis.
• • Receiving paracetamol and ketoprofen postoperatively.
• • Under general anesthesia or spinal anesthesia (without intrathecal morphine).
• • Participant affiliated to a social security scheme
• • Participant's free, informed and written consent
• Exclusion Criteria:
• • Septic or carcinological surgery
• • Allergy to paracetamol, nefopam or NSAIDs
• • Angle-closure glaucoma
• • Prostate adenoma
• • history of convulsion
• • Nocturnal pollakiuria in men with more than two risings per night
• • Severe hepatic (Child C) or cardiac insufficiency (LVEF \< 30%)
• • Renal insufficiency with creatinine clearance \< 50 mL/ min according to Cockroft's formula
• • Active peptic ulcer or history of digestive bleeding or peptic perforation
• • Patients with opioid treatment for chronic pain other than coxarthrosis (fentanyl, oral morphine \> 50mg/d or equivalent)
• • Protected patient: safeguard of justice, guardianship or curatorship
• • Incomprehension or inability to use a numerical rating scale or to self-assess/manage pain
• • Pregnancy or breast-feeding